Tonizep Orally Disintegrating Tablet 5mg

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

Donepezil hydrochloride monohydrate

Διαθέσιμο από:

IMEKS PHARMA SDN. BHD.

INN (Διεθνής Όνομα):

Donepezil hydrochloride monohydrate

Μονάδες σε πακέτο:

14x2 Tablets

Κατασκευάζεται από:

T.O. CHEMICALS (1979) LTD.

Φύλλο οδηγιών χρήσης

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
TONIZEP ORALLY DISINTEGRATING TABLET 5MG
Donepezil hydrochloride (5 mg Donepezil Hydrochloride tablets each
containing 4.56 mg donepezil free base)
_ _
1
forodis
WHAT IS IN THE LEAFLET
1.
What
_Tonizep Orally Disintegrating _
_Tablet 5mg_
is used for
2.
How
_Tonizep Orally Disintegrating _
_Tablet 5mg_
works
3.
Before you use
_Tonizep Orally _
_Disintegrating Tablet 5mg_
4.
How to use
_Tonizep Orally _
_Disintegrating Tablet 5mg_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Tonizep Orally _
_Disintegrating Tablet 5mg_
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT _TONIZEP ORALLY DISINTEGRATING TABLET _
_5MG_
IS USED FOR
_Tonizep Orally Disintegrating Tablet 5mg _
is
a prescription medicine to treat dementia in
Alzheimer’s disease. The symptoms
include increasing memory loss,
confusion and behavioural changes. As
a result, sufferers of Alzheimer’s
disease find it more and more difficult
to carry out their normal daily
activities.
HOW _TONIZEP ORALLY DISINTEGRATING TABLET _
_5MG_
WORKS
_Tonizep Orally Disintegrating Tablet 5mg_
will not cure this disease, but should help
your memory and improve your ability to
think more clearly. This medicine belongs to
a group of medicines called
acetylcholinesterase inhibitors. They are
thought to work by increasing the levels of a
substance (acetylcholine) in the brain
involved in memory function by slowing
down the breakdown of acetylcholine.
_Tonizep Orally Disintegrating Tablet 5mg_
has not been approved as a treatment for any
medical condition in children.
BEFORE YOU USE _TONIZEP ORALLY _
_DISINTEGRATING TABLET 5MG _
-
_When you must not use it _
Do not use
_Tonizep Orally Disintegrating _
_Tablet 5mg_
if:
•
you are phenylketonurics
•
you are allergic to donepezil hydrochloride
or any ingredients in
_Tonizep Orally _
_Disintegrating Tablet 5mg_
or to medicines
that contain piperidines.
•
you are pregnant or breast-feeding, think
you may be

Αρχείο Π.Χ.Π.

TONIZEP
® ORALLY DISINTEGRATING TABLET 5MG
CONTENT
Each 5 mg donepezil hydrochloride tablets each containing 4.56 mg
donepezil free base.
DESCRIPTION
White, round tablets embossed with ‘5’ on one side and ‘ZD’ on
another
PHARMACODYNAMICS
Donepezil hydrochloride is a specific and reversible inhibitor of
acetylcholinesterase, the predominant cholinesterase in the
brain. Donepezil hydrochloride is in vitro over 1000 times more potent
an inhibitor of this enzyme than of butyryl
cholinesterase, an enzyme which is present mainly outside the central
nervous system.
ALZHEIMER'S DEMENTIA
Administration of single daily doses of 5 mg or 10 mg of donepezil
hydrochloride produced steady-state inhibition of
acetylcholinesterase activity (measured in erythrocyte membranes) of
63.6% and 77.3%, respectively when measured post dose.
The inhibition of acetylcholinesterase (AChE) in red blood cells by
donepezil hydrochloride has been shown to correlate to
changes in ADAS-cog, a sensitive scale which examines selected aspects
of cognition.
The potential for donepezil hydrochloride to alter the course of the
underlying neuropathology has not been known. Thus,
donepezil hydrochloride cannot be considered to have any effect on the
progress of the disease.
An analysis was done at the conclusion of donepezil hydrochloride
treatment using a combination of three efficacy criteria:
the ADAS-Cog (a measure of cognitive performance), the Clinician
Interview Based Impression of Change with Caregiver Input
(a measure of global function) and the Activities of Daily Living
Subscale of the Clinical Dementia Rating Scale (a measure of
capabilities in community affairs, home and hobbies and personal
care).
Those fulfilled the criteria listed below were considered treatment
responders.
Response =
Improvement of ADAS-Cog of at least 4 points
No deterioration of CIBIC+
No Deterioration of Activities of Daily Living Subscale of the
Clinical Dementia Rating Scale
% Response
Intent to Treat Population n = 365
Evaluable Population n = 352
Placebo G